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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
genetic toxicity in vivo
Remarks:
Type of genotoxicity: other: Mikronuclei
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No OECD guideline or GLP defined.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1993
Reference Type:
publication
Title:
Unnamed
Year:
1995

Materials and methods

Principles of method if other than guideline:
other; Micronucleus assay
GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Tris(2-ethylhexyl) phosphate
EC Number:
201-116-6
EC Name:
Tris(2-ethylhexyl) phosphate
Cas Number:
78-42-2
Molecular formula:
C24H51O4P
IUPAC Name:
tris(2-ethylhexyl) phosphate
Details on test material:
no data

Test animals

Species:
mouse
Strain:
B6C3F1
Sex:
male

Administration / exposure

Route of administration:
intraperitoneal
Duration of treatment / exposure:
5 d
Frequency of treatment:
injection once daily on 3 consecutive days
Doses / concentrations
Remarks:
Doses / Concentrations:

Basis:
other: intraperitoneal injection of 0, 500, 1000, 2000 mg/kg test substance
No. of animals per sex per dose:
5-6
Control animals:
yes

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
valid
Negative controls validity:
not specified
Positive controls validity:
valid

Any other information on results incl. tables

Tris(2 -Ethylhexyl)Phosphate

Overall result: Negative

The initial test gave a positive trend to 2,000 mg/kg with 1.1 MN-PCE/1,000 PCE in the control and 3.9 MN-PCE/1,000 PCE in the high dose group. Two repeat studies, one

to 2,000 mg/kg and one to 3,000 nng/kg were not positive by trend analysis and no dose groups were significantly elevated. Based on the lack of reproducibility of the effect seen in the initial test, this chemical is considered negative.

Initial Test:

Chemicala)  Tissueb)  Trendc) p value  Dosed) (mg/kg)  MN-PCE/1000e) (No.animals)  Pair-wisef)  Survivalg) %PCEh) 
   Tris(2 -ethylhexyl)phosphate (C)  BM  <0.001  0  1.10 +/-0.40(5)    5/5  49.9
 Negative -/-       500  1.90 +/-0.10(5)  0.0719  5/5  46.4
       1000  3.20 +/- 0.82 (5)  <0.001  5/5  54.7
       2000  3.90 +/- 0.62(5)  <0.001  6/6  46.7

a) Chemical name

b) Tissue used (BM=bone marrow)

c) Value of P for trend analysis alpha= .05

d) chemical concentration administered i.p. daily to each animal

e) Micronucleated PCEs per 1000 PCE scored (+/- Standard Error of the Means) (Number of the Animals Scored).

f) The value of P fpr pair-wise comparisons between each treatment group and the concurrent solvent group alpha= .05.

g) No. of animals surviving treatment over number of animals treated

h) Percentage of erythrocytes that were polychromatic

Applicant's summary and conclusion

Executive summary:

In an mouse bone marrow micronucleus assay the test substance was tested with following doses administered intraperitoneally to mice: 0, 500, 1000, 2000 mg/kg bw. The result was negative.